The Simultaneous Use of Supraclavicular and Distal Blocks

November 20, 2013 updated by: Basak Ceyda MECO, Ankara University

Can we Gain an Advantage by Combining Distal Median, Radial and Ulnar Nerve Blocks With Supraclavicular Block? A Randomized Controlled Study

The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block alone.

Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every 5 minutes starting at the 10th minutes. The imaging, needling and performance times will be recorded. Also the onset and anesthesia related times, need for analgesic and first analgesic time will be noted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06700
        • Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 and 80 years old patient
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective hand and forearm surgery

Exclusion Criteria:

  • patient refusal
  • preexisting neuropathy
  • coagulopathy
  • allergy to agents used
  • pregnancy
  • body mass index > 35 kg/m2
  • chronic obstructive pulmonary disease
  • infection or previous surgery in the supraclavicular area
  • systemic infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: supraclavicular block
A supraclavicular block with 32 mL of lidocaine 1.5% + epinephrine 5µg/mL was performed for the anaesthetic management of the forearm and hand.
Drug: Lidocaine
Drug: Epinephrine
Procedure: intravenous cannulation.
A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site
Device: Intravenous cannulation.
A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site
Device: Routine ASA monitoring
Monitorization with ECG, noninvasive blood pressure and spO2.
Drug: Premedication midazolam
Premedication with 0.03 mg/kg midazolam iv
ACTIVE_COMPARATOR: Supraclavicular and median, ulnar, radial blocks
Patients in this group received 20 mL of lidocaine 1.5% + epinephrine 5µg/mL for supraclavicular block and after the supraclavicular block they recieved a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve).
Drug: Lidocaine
Drug: Levobupivacaine
Drug: Epinephrine
Device: Intravenous cannulation.
A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site
Device: Routine ASA monitoring
Monitorization with ECG, noninvasive blood pressure and spO2.
Drug: Premedication midazolam
Premedication with 0.03 mg/kg midazolam iv
Procedure: Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks.
Supraclavicular block with 20 mL of lidocaine 1.5% + epinephrine 5µg/mL and the addition of ultrasound-guided ulnar, median and radial nerve blocks. For that 12 mL of local anesthetic solution of a 50:50 mixture of lidocaine 2% and levobupivacaine 0.5% (4 mL/nerve) was used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time required after a supraclavicular block alone or a supraclavicular block combined with distal blocks, to achieve a sensory and motor block needed for surgery.
Time Frame: All patients will be followed up during the block procedure and during the surgery. Also, after the surgery patients will be followed up to 7 days postoperatively.
The onset time of supraclavicular plexus block and the onset time of supraclavicular block combined with distal median, radial, and ulnar nerve blocks will be followed up. The time needed to achieve a surgical block will be assessed in both groups. The difference between the 2 groups will be compared and analysed. For this an investigator blinded to the group allocation will evaluate the sensorial pinprick and motor blocks of the ulnar, median, radial and musculocutaneous nerves every 5 minutes starting at the 10th minutes until 30th minutes.
All patients will be followed up during the block procedure and during the surgery. Also, after the surgery patients will be followed up to 7 days postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (ESTIMATE)

November 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-99-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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